Study Start-Up Specialist
6 days ago
We are seeking a highly skilled and experienced Study Start-Up Specialist to join our team at Nova Scotia Health Authority. As a key member of our Research and Innovation team, you will play a critical role in supporting the clinical study start-up phase.
Key Responsibilities:
- Provide direct support to investigators and their teams during the clinical study start-up phase.
- Guide and support multiple administrative activities, including contracting, REB submissions, and other tasks as required by the assigned clinical research group.
- Independently manage multiple study and site level deliverables during the study start-up phase.
- Work with the Research and Innovation team and stakeholders to develop institutional processes and provide recommendations for ways in which these processes can be improved.
- Provide strategic advisory support as needed to accelerate study startup processes.
- Support Principal Investigators (PIs) during Feasibility Assessment, Site Selection Visit (SSV), and Site Initiation Visit (SIV).
- Maintain communication with Investigative sites, Sponsors, and Study Operations Team regarding the status of contracts and contract-related documents.
- Prepare and oversee preparation of budget, contractual documents, and correspondence.
- Facilitate the indemnification process between the study Sponsor and the site.
- Establish, maintain, and deliver Sponsor/CRO communication as well as actions, decisions, and issues, as required.
Requirements:
- Master's Degree or minimum of 4 years related education and experience required.
- Minimum 5 years experience in project management is considered a strong asset.
- Minimum 5 years of experience in a senior administrative coordination role in a clinical research set-up is considered a strong asset.
- Current knowledge of and the ability to apply ICH/GCP and all applicable regulations and guidelines.
- Well-versed on local Health Authority and Ethics Committees requirements.
- Leadership competencies including analytical thinking, action management, team leadership, initiative, collaboration, negotiation, persuasion, relationship building, and diversity proficiency and awareness.
- Ability to develop project/process workflows.
- Experienced in stakeholder engagement and alliance management.
- Knowledge of the health sciences research enterprises in a university setting, particularly in relation to hospital-based research, and knowledge of the national research environment.
- An in-depth knowledge and understanding of clinical research processes, regulations, and methodology.
- Competent in both written and verbal communication.
- Experience working with diversity of staff and stakeholders, with knowledge of cultural competence, diversity, and social inclusion.
- Ability to work closely and effectively with a diverse cross-functional group of administrators; strong interpersonal and leadership skills; proven ability to effect and influence change through collaborative and inclusive style.
- Ability to anticipate needs, respond accordingly, provides guidance and support.
- Sound knowledge of information systems.
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Halifax, Nova Scotia, Canada Nova Scotia Health Authority Full timeAbout the OpportunityWe are seeking a highly skilled and experienced Study Start-Up Specialist to join our team at Nova Scotia Health Authority. The successful candidate will provide direct support to investigators and their teams during the clinical study start-up phase, guiding and supporting multiple administrative activities as required by the assigned...
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Halifax, Nova Scotia, Canada Nova Scotia Health Authority Full timeAbout the OpportunityWe are seeking a highly skilled and experienced Study Start-Up Specialist to join our team at Nova Scotia Health Authority. The successful candidate will provide direct support to investigators and their teams during the clinical study start-up phase, guiding and supporting multiple administrative activities as required by the assigned...
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